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* = Presenting author

P711 Clinical characteristics of patients with Crohn’s disease or ulcerative colitis treated with vedolizumab: a real-world data analysis

H. Liang1, S. Manne1, J. Shick1, S. Yu1, G. Fusco1, P. Dolin*2

1Takeda Development Centre Americas, Inc, Deerfield, Illinois, United States, 2Takeda Development Centre Europe Ltd, London, United Kingdom

Background

Vedolizumab has been available since June 2014 in the United States for treatment of adults with ulcerative colitis (UC) or Crohn’s disease (CD). This study aims to describe clinical characteristics of CD or UC patients initiating Entyvio during its first year of use in the United States.

Methods

A non-interventional, retrospective analysis was done using the Optum insurance claims database covering the period May 1, 2000, through June 30, 2015. Patients meeting all of the following criteria were included in the analysis: patients had a diagnosis of UC or CD; patients had both medical and pharmacy insurance coverage; patients received at least 1 vedolizumab infusion from June 1, 2014, to June 30, 2015; and patients had continuous insurance enrolment for 6 months before vedolizumab use. Descriptive statistics were used to describe and compare CD and UC patients.

Results

In total, 304 patients initiating vedolizumab were identified; 63% had CD, and 37% had UC. The CD patients were mostly female (61%) and had a mean of about 5-years duration of IBD; 83% were switching from an anti-tumour necrosis factor-alpha (anti-TNF-α)/natalizumab to vedolizumab, and 17% were using vedolizumab as their first biologic agent. Conversely, the UC patients were mostly male (59%) and had a mean of only about 3-years duration of inflammatory bowel disease (IBD); 78% were switching from an anti-TNF-α/natalizumab, and 22% were using vedolizumab as their first biologic agent. Each of the differences between CD and UC patients were statistically significant (p < .05). In the 60 days before initiation of vedolizumab, CD patients’ medication use included corticosteroids (52% of patients), anti-TNF- α (26%), immunosuppressants (22%) (of which, AZA [14%], 5-ASAs [19%], and antibiotics [16%]). Amongst the UC patients, medication in 60 days before initiation of vedolizumab included corticosteroids (67%), 5-ASAs (45%), anti-TNF-α (41%), immunosuppressants (27%) (of which, AZA [15%]), and antibiotics (13%). Analysis of medical claims before initiating vedolizumab showed that CD patients were more likely than UC patients to have had gastrointestinal (GI) infections (73% vs 62%), opportunistic infections (37% vs 21%), and opportunistic fungal infections (18% vs 7%). Each of those differences was statistically significant (p < 0.05). No statistical differences were found for upper respiratory tract infections (CD 71% vs UC 63%) and lower respiratory tract infections (13% vs 9%) between CD and UC patients (p >0.05).

Conclusion

Most of patients who initiated vedolizumab in the first year after launch in the US were CD patients. These CD patients had longer duration of IBD and were more likely to have previously had an opportunistic infection or a GI infection compared with UC patients initiating vedolizumab.